Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

NCT ID: NCT05839509

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-06
• Study Completion Date: 2024-12-05

Brief Summary

This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 participants with clinically diagnosed bipolar disorder (BD) type II and experiencing a current episode of depression will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day.

Conditions

Bipolar II Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GH001 Individualized Dosing Regimen

GH001 (Mebufotenin, 5-Methoxy-N,N-Dimethyltryptamine) is administered via inhalation, as an IDR consisting of up to 3 increasing doses of GH001 (6 mg, 12 mg, and 18 mg), on a single day. The second and third doses are only administered if the patient did not achieve intense psychoactive effects (a peak experience \[PE\]) at the previously administered dose.

Group Type: EXPERIMENTAL

GH001

Intervention Type: DRUG

GH001 administered via inhalation

Interventions

GH001

GH001 administered via inhalation

Intervention Type: DRUG

Other Intervention Names

5-Methoxy-N,N-Dimethyltryptamine; 5-MeO-DMT; Mebufotenin

Eligibility Criteria

Inclusion Criteria

• Is male or female and in the age range between 18 and 64 years (inclusive) at screening
• Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at screening
• Meets the trial criteria for bipolar II disorder and is experiencing a major depressive episode, as assessed by a trial psychiatrist or registered clinical psychologist

Exclusion Criteria

• Has bipolar II disorder with rapid cycling (four or more episodes of hypomania or depressive episodes in previous 12-month period)
• Has, based on history, psychiatric assessment, and evaluation of the MINI, a current or prior diagnosis of bipolar I disorder, a manic episode, a psychotic disorder, MDD or other mood disorder with psychotic features, obsessive compulsive disorder, PTSD, autism spectrum disorder, borderline personality disorder, schizophrenia, delusional disorder, paranoid personality disorder, schizoaffective disorder, clinically significant intellectual disability, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to the investigator's judgment
• Has one or more first degree relatives with a current or previously diagnosed psychotic disorder, bipolar I disorder or MDD with psychotic features
• Has taken prohibited medication or prohibited dietary supplements within the specified timeframe prior to dosing
• Has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug according to the investigator's judgment
• Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters which renders the patient unsuitable for the trial according to the investigator's judgment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GH Research Ireland Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigational Site

Dresden, , Germany

Investigational Site

Frankfurt, , Germany

Investigational Site

Münster, , Germany

Investigational Site

Leiden, , Netherlands

Investigational Site

Maastricht, , Netherlands

Investigational Site

London, , United Kingdom

Investigation Site

Oxford, , United Kingdom

Countries

Germany; Netherlands; United Kingdom

Other Identifiers

GH001-BD-202

Identifier Type: -

Identifier Source: org_study_id